|
Product Name |
Agomelatine |
|
Chemical Name |
N-[2-(7-Methoxy-1-naphthyl)ethyl]acetamide |
|
Appearance |
White or off-white powder |
|
Purity |
99% by HPLC |
|
CAS Number |
138112-76-2 |
|
Molecular formula |
C₁₅H₁₇NO₂ |
|
Solubility |
Insoluble water(< 1 mg/mL) |
|
Storage |
Store at -20°C (Stable for up to 6 months) |
Products Description
What is Agomelatine?
Agomelatine has a unique dual mechanism that distinguishes it from all other antidepressants. It is a new antidepressant that works by regulating the circadian clock (MT1/MT2 agonist) and enhancing norepinephrine/dopamine in the prefrontal cortex (5-HT2C antagonism). It is effective for depression and can improve anxiety and sleep, especially for depressed patients who worry about sexual dysfunction or weight gain. However, it has potential risks to liver function, requiring patients to strictly and regularly monitor liver function before and during treatment, which is the core prerequisite for its safe use.
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Applications of Agomelatine
| Application Area | Specific Use | Status |
|---|---|---|
| Major Depressive Disorder (MDD) | Acute treatment and relapse prevention in adults -2-3-10. | Approved |
| Generalized Anxiety Disorder (GAD) | Treatment of GAD in adults -2-4-5. | Approved (in some regions) |
| Co-morbid Physical Illness | Depression in patients with cardiovascular, neurological, or post-COVID-19 conditions -4. | Clinical Use |
| Sexual Dysfunction | Treatment option for patients concerned about SSRI/SNRI-induced sexual side effects -3-4. | Clinical Advantage |
| Cognitive/Memory Disorders | Potential treatment for memory/cognitive impairment in neurodegenerative diseases (e.g., Alzheimer's) -7-9. | Investigational |
| Neurodevelopmental Disorders | Potential treatment for ADHD and Autism Spectrum Disorder -1. | Investigational (limited data) |
Summary Table of Agomelatine's Specific Benefits
| Benefit Category | Specific Benefit | Key Finding / Patient Group |
|---|---|---|
| Metabolic Health | Lower risk of hypertension, diabetes, and hyperlipidemia | Reduced risk by 20%, 12.5%, and 6% vs. fluoxetine in a 5-year cohort study (2026)-4. |
| Diabetes Co-morbidity | Improved glycemic control & psychiatric symptoms | Reduces HbA1c and fasting glucose; efficacy superior to SSRIs for anxiety in diabetic patients (2024)-1-7. |
| Depression Treatment | Faster improvement of anhedonia, fatigue, and sleep | Faster onset within 2 weeks vs. SSRIs; improves motivation, pleasure, and sleep quality (2023)-5. |
| Tolerability | No sexual dysfunction; neutral weight | No negative effect on sexual function; can normalize existing dysfunction-1-3-8. |
| Neurodegenerative Disease | Improvement in dementia-related behavioral symptoms | Significant improvement in BPSD symptoms, including depression, anxiety, and sleep problems |
Important Note on Efficacy: A 2013 meta-analysis of published and unpublished trials found that while acute treatment with agomelatine showed a statistically significant superiority over placebo, the effect size was small (-1.51 points on the HRSD scale), and the authors concluded that a clinically important difference is unlikely. The analysis also noted evidence of substantial publication bias -2. However, more recent large-scale and real-world studies continue to highlight its specific advantages in symptom domains and tolerability.
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CONTACT PAGE
1.Inquiry methods：
Email:alice@xaheshun.com
Whatspp:+8618509260106
Online instant messaging
2.Contact Information：
Name：Alice
Telephone :+8618509260106
Email:alice@xaheshun.com
FAQ
Q1:What is the purity level and standard of your Agomelatine powder?
A: Our Agomelatine API meets or exceeds the current EP (European Pharmacopoeia) and USP (United States Pharmacopeia) standards. We provide a comprehensive Certificate of Analysis (CoA) for every batch, detailing an assay of ≥99.0% (on a dried basis) with strictly controlled related substances.
Q2 :Do you have a Drug Master File (DMF) available for Agomelatine?
A: Yes, we maintain an active DMF (USDMF and/or EDMF/ASMF) for our Agomelatine. Upon signing a CDA/NDA, we can provide the Letter of Access (LoA) to support your marketing authorization applications and regulatory filings with the FDA or EMA.
Q3:What regulatory documentation can you provide for import and registration?
A: To support your regulatory submission and import process, we provide a comprehensive documentation package, including Certificate of Analysis (COA), MSDS, and ROS (Route of Synthesis). For bulk long-term cooperation, we can also discuss providing DMF (Drug Master File) technical support.
Q4:How do you control the impurities and particle size of Agomelatine?
A: We employ advanced crystallization technology to control impurity profiles and residual solvents within ICH limits. Regarding physical properties, we offer customized particle size distribution (PSD) (e.g., micronized powder) to ensure optimal bioavailability and formulation stability for your finished dosage forms.
Q5：What is the MOQ (Minimum Order Quantity) and Lead Time for international air freight?
A: Our standard MOQ is 1kg-5kg for trial orders. For bulk orders (25kg+), the typical lead time is 5-7 working days from payment to dispatch. We provide full documentation for customs clearance (Commercial Invoice, Packing List, CoA, SDS).
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